2.Analysis on the Beneficiary Population of Beijing TCM Dominant Diseases Treatment Costs Based on SHA 2011
Zixuan DAI ; Liming LIU ; Xiaowei MAN ; Wei CHENG
Chinese Health Economics 2024;43(2):45-48
Objective:It analyzed the population aggregation characteristics of the treatment costs for Traditional Chinese Medi-cine(TCM)dominant diseases,and make targeted recommendations for relevant health policies.Methods:A total of 205 medical insti-tutions were obtained through stratified whole-cluster sampling to analyze the composition of the beneficiary population based on Sys-tem of Health Accounts 2011 for the treatment costs of TCM dominant diseases for local residents in Beijing in 2019.Results:The treatment costs of Beijing's TCM dominant diseases are dominated by diseases that include basic western medicine treatment,with male patients'costs accounting for a higher proportion than those of females,and the trend of younger patients in types of diseases treated by TCM and the costs have mainly flowed to females,with more than 50%of the treatment costs being consumed by patients aged 60 years old and above.Conclusion:It is needed to pay attention to male and child patients aged 0~14 years and their priority diseases,strengthen the construction of Chinese medicine geriatric health services,and adopt differentiated strategies for different groups of people so as to maximize the advantages of Chinese medicine.
3.Level of coagulation factor Xin patients with venous thrombosis of lower limbs and its correlation with recurrence risk
Haijun JIANG ; Ronghua LI ; Guoping CHEN ; Li WANG ; Jun HOU ; Xiaokang CHENG ; Liming YU
Chinese Journal of Geriatric Heart Brain and Vessel Diseases 2024;26(2):151-154
Objective To investigate the level of coagulation factor Ⅺ(FⅪ)in patients with venous thrombosis of lower limbs and its correlation with recurrence risk.Methods A total of 220 pa-tients with deep vein thrombosis(DVT)admitted in our hospital from February 2018 to February 2019 were enrolled as the study group,and another 50 healthy individuals taking physical exami-nation during same period served as the control group.After a 3 years followed,the study group ultimately included 197 cases,according to the results of restricted cubic spline(RCS),the study group was divided into low(FⅪ<10.3 U/L,94 cases),medium-(10.3-12.1 U/L,52 cases)and high-level groups(>12.1 U/L,51 cases).The plasma level of FⅪ was detected in the study group 1 month after the end of anticoagulant therapy,and the results were compared with those of the control group during physical examination.Cox model was used to analyze the influence of FⅪ on the recurrence of DVT,and RCS was employed to analyze the relationship between DVT recur-rence and FⅪ level.Kaplan-Meier curve was plotted to analyze the recurrence risk of DVT with different FⅪ levels.The patients from the study group were followed up for 3 years.Results The FⅪ level was significantly higher in the study group than the control group(P<0.05).During fol-low-up period,33 patients(16.75%)had DVT recurrence.The Cox model analysis after adjust-ment of sex and age showed that FⅪ level was a risk factor for DVT recurrence(P<0.05).When the FⅪ level was set into tertile and the risk ratio was calculated after adjustment,FⅪ<10.3 U/L,and the average FⅪ level at this stage was 9.2 U/L,the risk ratio was 0.82(95%CI:0.673-0.984);Patients with FⅪ between 10.3 and 12.1 U/L,and the average FⅪ at this stage was 11.4 U/L,the risk ratio of 1.04(95%CI:0.813-1.432).The those with FⅪ>12.1 U/L,and the average FⅪ at this stage was 13.8 U/L,hazard ratio of 1.38(95%CI:0.921-1.563).Kaplan-Meier curve analysis showed that the recurrence risk was 28.62%(95%CI:25.633-31.609),30.10%(95%CI:27.594-32.606)and 38.06%(95%CI:34.306-41.371),respectively for the low-,medium-,and high-level groups,with significant correlation among the three groups(x2=6.631,P=0.036).Conclusion Compared with healthy individuals,plasma FⅪ level is at a high level in the DVT patients.With the increment of FⅪ level,the risk of DVT recurrence increases.Two FⅪ levels,10.3 U/L and 12.1 U/L,can be used as reference points for the obvious increase of DVT recur-rence rate.
4.Efficacy and safety of CM310 in moderate-to-severe atopic dermatitis: A multicenter, randomized, double-blind, placebo-controlled phase 2b trial
Yan ZHAO ; Jianzhong ZHANG ; Bin YANG ; Jingyi LI ; Yangfeng DING ; Liming WU ; Litao ZHANG ; Jinyan WANG ; Xiaohong ZHU ; Furen ZHANG ; Xiaohua TAO ; Yumei LI ; Chunlei ZHANG ; Linfeng LI ; Jianyun LU ; Qingchun DIAO ; Qianjin LU ; Xiaoyong MAN ; Fuqiu LI ; Xiujuan XIA ; Hao CHENG ; Yingmin JIA ; Guoqing ZHAO ; Jinchun YAN ; Bo CHEN
Chinese Medical Journal 2024;137(2):200-208
Background::Atopic dermatitis (AD) affects approximately 10% of adults worldwide. CM310 is a humanized monoclonal antibody targeting interleukin-4 receptor alpha that blocks interleukin-4 and interleukin-13 signaling. This trial aimed to evaluate the efficacy and safety of CM310 in Chinese adults with moderate-to-severe AD.Methods::This multicenter, randomized, double-blind, placebo-controlled, phase 2b trial was conducted in 21 medical institutions in China from February to November 2021. Totally 120 eligible patients were enrolled and randomized (1:1:1) to receive subcutaneous injections of 300 mg CM310, 150 mg CM310, or placebo every 2 weeks for 16 weeks, followed by an 8-week follow-up period. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Eczema Area and Severity Index (EASI-75) score from baseline at week 16. Safety and pharmacodynamics were also studied.Results::At week 16, the proportion of EASI-75 responders from baseline was significantly higher in the CM310 groups (70% [28/40] for high-dose and 65% [26/40] for low-dose) than that in the placebo group (20%[8/40]). The differences in EASI-75 response rate were 50% (high vs. placebo, 95% CI 31%–69%) and 45% (low vs. placebo, 95% CI 26%–64%), with both P values <0.0001. CM310 at both doses also significantly improved the EASI score, Investigator’s Global Assessment score, daily peak pruritus Numerical Rating Scale, AD-affected body surface area, and Dermatology Life Quality Index compared with placebo. CM310 treatment reduced levels of thymus and activation-regulated chemokine, total immunoglobulin E, lactate dehydrogenase, and blood eosinophils. The incidence of treatment-emergent adverse events (TEAEs) was similar among all three groups, with the most common TEAEs reported being upper respiratory tract infection, atopic dermatitis, hyperlipidemia, and hyperuricemia. No severe adverse events were deemed to be attributed to CM310. Conclusion::CM310 at 150 mg and 300 mg every 2 weeks demonstrated significant efficacy and was well-tolerated in adults with moderate-to-severe AD.Trial Registration::ClinicalTrials.gov, NCT04805411.
5.An observational and Mendelian randomization study of the associations of body mass index with plasma amino acids and acylcarnitines in Chinese adults
Si CHENG ; Ting WU ; Canqing YU ; Dianjianyi SUN ; Pei PEI ; Huaidong DU ; Junshi CHEN ; Zhengming CHEN ; Yuanjie PANG ; Jun LYU ; Liming LI
Chinese Journal of Epidemiology 2024;45(6):770-778
Objective:To explore the relationship between BMI and levels of plasma amino acids and acylcarnitines in Chinese adults.Methods:Based on 2 182 individuals with targeted mass spectrometry metabolomic measurements from the first resurvey of the China Kadoorie Biobank, we assessed the linear and nonlinear associations between BMI and plasma levels of 20 amino acids and 40 acylcarnitines using linear regression models and restricted cubic spline models, and identified BMI-related metabolic pathways. We conducted one-sample Mendelian randomization (MR) with BMI genetic risk scores as the instrumental variable further to explore the potential causal relationships between BMI and 20 amino acids and 40 acylcarnitines, and tested for horizontal pleiotropy using the MR-Egger method.Results:Observational analyses found that BMI was associated with increased plasma levels of 3 branched-chain amino acids (isoleucine, leucine, and valine), 2 aromatic amino acids (phenylalanine and tyrosine), 3 other amino acids (cysteine, glutamate, lysine), and 7 acylcarnitines (C3, C4, C5, C10, C10:1, C14, and C16), and with decreased circulating levels of asparagine, serine, and glycine. Pathway analysis identified 7 BMI-related amino acids metabolic pathways (false discovery rate corrected all P<0.05), including branched-chain amino acids and aromatic amino acids biosynthesis, glutathione metabolism, etc. BMI showed a nonlinear relationship with leucine, valine, and threonine, and a linear relationship with other amino acids and acylcarnitines. One-sample MR analyses revealed that BMI was associated with elevated levels of tyrosine and 4 acylcarnitines [C5-DC(C6-OH), C5-M-DC, C12-DC, and C14], with tyrosine and acylcarnitine C14 positively correlated with BMI in both observational [the β values (95% CIs) were 0.057 (0.044-0.070) and 0.018 (0.005-0.032), respectively] and One-sample MR analyses [the β values (95% CIs) were 0.102 (0.035-0.169) and 0.104 (0.036-0.173), respectively]. The MR analyses of the current study satisfied the 3 core assumptions of instrumental variable. Conclusions:BMI was associated with circulating 11 amino acids and 7 acylcarnitines in Chinese adults, involving several pathways such as branched-chain amino acid and aromatic amino acid metabolism, fatty acid metabolism, and oxidative stress. There may be a causal relationship between BMI and tyrosine and acylcarnitine C14.
6.Application of EXODUS system combined with allosteric DNA nanoswitches in the detection of miR-107 among plasma exosomes of Parkinson′s disease patients
Chinese Journal of Preventive Medicine 2024;58(8):1191-1196
This study aimed to achieve rapid detection of Parkinson′s disease (PD) plasma exosome miR-107. A case-control design was used to collect ten Parkinson′s disease and ten healthy control plasma samples from the Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from December 2023 to January 2024. Exosome detection via the ultrafast-isolation system (EXODUS) was used to isolate plasma exosomes. The nanoparticle tracking analysis technology and electron microscopy were used to identify exosome particle size and morphology. The Qiagen miRNeasy Micro Kit was used to extract RNA. The microRNA-activated conditional looping of engineered switches (miRacles) was used to detect miR-107, and the relative expression was analyzed by agarose gel electrophoresis. Thermo Fisher RevertAid RT Reverse Transcription Kit was used to perform reverse transcription of RNA, and real-time PCR was used to detect miR-107. The independent samples t-test was used for comparison between groups. EXODUS system completed the isolation of exosomes from 500 μl plasma within 1.5 hours. The exosome concentration (mean±SD) was (4.82±2.02)×10 10 particles/ml in the control group and (5.08±2.34)×10 10 particles/ml in the PD group. There was no significant difference in exosome concentration between PD patients and healthy controls ( t=-0.168, P=0.872). The morphology of exosomes was confirmed by electron microscopy. The miRacles nanoswitch could detect fM-level miR-107 and also effectively distinguish miR-107 from its family members, including miR-15a and miR-16. Agarose gel electrophoresis showed that the mean±SD of relative grey value content was 1.00±0.26 in the control group and 1.86±0.21 in the PD group. The miR-107 in the PD group was significantly higher than that in the control ( t=-8.143, P<0.001), which was consistent with the result of real-time PCR. EXODUS combined with miRacles could achieve rapid, non-enzymatic and cheap detection of plasma exosomal miR-107 in PD patients.
7.Application of EXODUS system combined with allosteric DNA nanoswitches in the detection of miR-107 among plasma exosomes of Parkinson′s disease patients
Chinese Journal of Preventive Medicine 2024;58(8):1191-1196
This study aimed to achieve rapid detection of Parkinson′s disease (PD) plasma exosome miR-107. A case-control design was used to collect ten Parkinson′s disease and ten healthy control plasma samples from the Department of Laboratory Medicine, Tongji Hospital, Tongji Medical College of Huazhong University of Science and Technology from December 2023 to January 2024. Exosome detection via the ultrafast-isolation system (EXODUS) was used to isolate plasma exosomes. The nanoparticle tracking analysis technology and electron microscopy were used to identify exosome particle size and morphology. The Qiagen miRNeasy Micro Kit was used to extract RNA. The microRNA-activated conditional looping of engineered switches (miRacles) was used to detect miR-107, and the relative expression was analyzed by agarose gel electrophoresis. Thermo Fisher RevertAid RT Reverse Transcription Kit was used to perform reverse transcription of RNA, and real-time PCR was used to detect miR-107. The independent samples t-test was used for comparison between groups. EXODUS system completed the isolation of exosomes from 500 μl plasma within 1.5 hours. The exosome concentration (mean±SD) was (4.82±2.02)×10 10 particles/ml in the control group and (5.08±2.34)×10 10 particles/ml in the PD group. There was no significant difference in exosome concentration between PD patients and healthy controls ( t=-0.168, P=0.872). The morphology of exosomes was confirmed by electron microscopy. The miRacles nanoswitch could detect fM-level miR-107 and also effectively distinguish miR-107 from its family members, including miR-15a and miR-16. Agarose gel electrophoresis showed that the mean±SD of relative grey value content was 1.00±0.26 in the control group and 1.86±0.21 in the PD group. The miR-107 in the PD group was significantly higher than that in the control ( t=-8.143, P<0.001), which was consistent with the result of real-time PCR. EXODUS combined with miRacles could achieve rapid, non-enzymatic and cheap detection of plasma exosomal miR-107 in PD patients.
8.Assessment of the clinical value with the application of serum abnormal prothrombin for auxiliary diagnosis of hepatocellular carcinoma: a multicenter Chinese population-based case-control study
Xieer LIANG ; Liming CHENG ; Songxiao XU ; Jun ZHANG ; Hongsong CHEN ; Cunying PU ; Rong FAN ; Jinlin HOU
Chinese Journal of Hepatology 2024;32(7):650-656
Objective:To comprehensively evaluate the clinical value of Elecsys serum abnormal prothrombin (PIVKA-Ⅱ) test reagent for auxiliary diagnosis of hepatocellular carcinoma (HCC) in the Chinese population.Methods:A multicenter case-control design was used in the study. Samples from patients with first-time confirmed, diagnosed, and untreated HCC, benign liver disease and interfering controls were collected continuously. Elecsys PIVKA-II and alpha-fetoprotein (AFP) were tested for analysis. Various clinical details of the subjects were collected and analyzed. The efficacy of PIVKA-II (21.29 ng/ml) and AFP (400 ng/ml) for HCC diagnosis was calculated at specific positive cut-off values. Statistical analysis was performed using the Kruskal-Wallis test or receiver operating characteristic curve.Results:A total of 448 subjects were eventually enrolled from five centers, including 185 HCC cases. PIVKA-II had a higher diagnostic sensitivity and accuracy than AFP (84.86% vs. 30.81% and 89.01% vs. 63.66%) when the benign liver disease group was used as the control group, while the specificity was slightly lower. A sensitive analysis showed that PIVKA-II had a sensitivity of >80% at this specific positive cut-off value in the subgroup of AFP-negative subjects, patients with different etiologies, and HCC patients with multiple Barcelona Clinic liver cancer stages (including early-stage HCC). At the same time, the PIVKA-II subject had a slightly higher area under the receiver operating characteristic curve than the AFP (0.920 0 vs. 0.880 9).Conclusion:The clinical efficacy of Elecsys PIVKA-Ⅱ is good and stable in the Chinese population. Additionally, it has the clinical potential to improve the current missed diagnosis status of AFP-negative HCC and HCC monitoring at an early stage, as well as the effectiveness of accuracy promotion for HCC auxiliary diagnosis in China.
9.Construction and practice of the first-class undergraduate course of Treatise on Febrile Diseases
Jun YANG ; Rui NIU ; Liming CHENG ; Yingying TAN ; Xiaohui LI ; Jingfeng YANG
Chinese Journal of Medical Education Research 2024;23(8):1050-1054
To explore the method of constructing the first-class undergraduate course of Treatise on Febrile Diseases. The undergraduates majoring in traditional Chinese medicine were selected as the teaching subjects. Three combinations (combination of theory and clinics, combination of science and education, and combination of ideological/political education and professional education) were adopted as the starting point. A variety of teaching methods were used. The combination of in-class and after-class and the combination of theory and clinics were implemented. Course construction was carried out from the aspects of course objectives, course resource construction, course content, organization and implementation, and course evaluation methods. Emphasis was placed on the process evaluation and formative evaluation. Questionnaire survey and final examination were used to evaluate the teaching effect. The results showed that a total of 10 first and second prizes were awarded in the provincial and municipal innovation competitions related to the theory of cold disease in the past three years. During the same time, more than 70 medical records were collected and collated, 82 research papers and 155 learning experiences were documented, five communities were visited along with the affiliated hospital and the school hospital for providing healthcare services in rural areas, and more than 20 traditional Chinese diagnosis and treatment activities were performed in these communities. The average score of students in overall course evaluation was 87. More than 94.00% (141/150) students highly evaluated the course construction. They believed that the course construction was very helpful to the theoretical study and clinical application of Treatise on Febrile Diseases, and improved their levels and abilities in classic reading, medical case evaluation and analysis, and syndrome differentiation and treatment. Students' recognition of this course has been improved and phased results have been achieved.
10.Latent profile analysis of impaired cognitive function and attribution among community-dwelling older adults with mild cognitive impairment
Liming SU ; Chen ZHANG ; Xiaoyan WANG ; Cheng HUANG ; Zhuqin WEI ; Xinhua SHEN ; Lina WANG
Chinese Journal of Behavioral Medicine and Brain Science 2024;33(6):519-526
Objective:To explore the potential categories and associated factors of mild cognitive impairment (MCI) in community-dwelling older adults.Methods:A total of 393 community-dwelling older adults with MCI in Huzhou City were selected through multistage random sampling from January to July 2022.The survey was conducted by the general information questionnaire, Montreal cognitive assessment (MoCA), Pittsburgh sleep quality index (PSQI) and 15-item geriatric depression scale(GDS-15). Latent profile analysis (LAP) was applied to explore latent categories based on the characteristics of cognitive impairment, and Logistic regression analysis was performed to examine the factors associated with these MCI categories. The statistical software was SPSS 26.0.Results:The community-dwelling older adults with MCI was categorized into four subgroups: generalized mildly impaired subgroup, mixed impaired with visuospatial executive dysfunction subgroup, narrative memory dysfunction impaired subgroup, and high-risk severely impaired subgroup, with corresponding MoCA scores of (23.10±0.96), (21.87±0.92), (20.43±0.93), (19.00±0.00), PSQI scores of (6.00 (4.00)), (7.00 (6.00)), (7.00 (6.00)), (10.00 (3.00)), and GDS-15 scores of (4.00 (4.00)), (4.00(5.00)), (6.00(5.00)), (8.00 (3.00)), respectively. Logistic regression analysis revealed that compared to generalized mildly impaired subgroup, gender, age, exercise habits, sleep quality, depressive symptoms, chronic disease count, and medication count significantly affected other three subgroups, with female, older age, and never/irregular exercise as common risk factors. Poor sleep quality and depressive symptoms could positively predict mixed impaired with visuospatial executive dysfunction subgroup and narrative memory dysfunction impaired subgroup( B=0.82, OR=2.27, 95% CI=1.26-4.08; B=1.12, OR=3.06, 95% CI=1.36-6.91).Additionally, poor sleep quality, depressive symptoms, chronic disease and medication count could significantly predict high-risk severely impaired subgroup ( B=4.13, OR=62.32, 95% CI= 1.71->999.99; B=3.31, OR=27.49, 95% CI=1.37-549.99; B=1.20, OR=3.32, 95% CI= 1.06-10.41 and B=0.80, OR=2.22, 95% CI=1.04-4.71). Conclusion:Four latent MCI categories are identified among community-dwelling older adults, and each category was characterized by unique cognitive impairment features and factors. Healthcare professionals are advised to customize assessments and management strategies according to these specific characteristics to effectively slow cognitive decline.

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